MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000263

Device Problem Difficult to Advance (2920)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) could not be negotiate through the sheath.The iab was tried from both right and left femoral artery.As a result, a new iab was used.There was no report of patient complications.

Manufacturer Narrative

Qn# (b)(4).No part has been returned to teleflex chelmsford for investigation.The reported complaint of catheter stuck in sheath is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.Additionally, it was noted from the complaint report that the user attempted to use different sheaths other than the sheaths supplied in the iabc kit, which can indicate that the user did not follow the instructions for use (ifu) and the iabc may get stuck in sheath or cause vascular damage.As a result, an in-service for the customer has been requested to reiterate the ifu and the importance of the sheath selection.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

Event Description

It was reported that the intra-aortic balloon (iab) could not be negotiate through the sheath.The iab was tried from both right and left femoral artery.As a result, a new iab was used.There was no report of patient complications.

Manufacturer Narrative

(b)(4).The serial number ((b)(6)) reported on the complaint report does not match the serial number on the returned sample.The serial number of the returned sample is ly71193.The lot number (18f19f0062) reported on the complaint report does not match the lot number for the returned sample.The lot number for the returned sample is 18f17l0044.Additional information obtained from a teleflex representative indicates the returned sample is the correct iab for this complaint.Additionally, the device was noted expired upon return, the device expiration date was october 2019.The reported event took place in november 2020.Returned for investigation was a 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that does not match the serial number on the returned sample.The sample was returned in a cardboard box and was loosely packed within original packaging tray.Returned with the sample were semi-finished kit components including 40cc inflation driveline tubing, 60cc luer-slip syringe, long arterial pressure tubing and semi-finished insertion kit components including two (2) 0.025in guidewire, 9.5fr teflon sheath w/dilator, 9fr super arrow-flex (saf) sheath w/sidearm and 8fr super arrow-flex (saf) sheath w/sidearm; no damage or abnormalities were noted to the returned components.The returned 8fr super arrow-flex (saf) sheath w/sidearm was noted from the 30cc iabc semi-finished insertion kit.Upon return, the peel away sheath was noted on the returned iabc.The one-way valve was noted tethered to the short driveline tubing.Some portion of the iabc bladder was noted within the original packaging tray.The exposed portion of the bladder was fully unwrapped.No kinks or bends were noted to the exposed portion of the iabc central lumen.No blood noted on the exterior surfaces of the returned iabc.No blood was noted within the helium pathway.The returned 9.5fr teflon sheath was noted with a dilator inserted and assembled with the sheath.The assembly was noted slightly bent; however, the bend likely occurred from customer handling or during sample return.No issues were noted to the sheath and dilator components, including the sheath hub and tip.No blood was noted on the exterior surfaces of the sheath/dilator and appeared unused.The sheath hub cap was removed, and the seal was visually inspected; no damage or abnormalities were noted.Vaseline/petroleum jelly was noted on the seal.The returned 9fr super arrow-flex (saf) sheath was visually inspected; no visual damage or abnormalities were noted to the returned sheath.The hub and the tip of the returned 9fr saf sheath appeared typical.No blood was noted on the exterior or the interior surfaces of the sheath and appeared unused.The sheath hub cap was removed, and the seal was visually inspected; no damage or abnormalities were noted.Vaseline/petroleum jelly was noted on the seal.The returned 8fr super arrow-flex (saf) sheath was visually inspected; no visual damage or abnormalities were noted to the returned sheath.The hub and the tip of the returned 8fr saf sheath appeared typical.No blood was noted on the exterior or the interior surfaces of the sheath and appeared unused.The sheath hub cap was removed, and the seal was visually inspected; no damage or abnormalities were noted.Vaseline/petroleum jelly was noted on the seal.The sheath in question was not returned with the sample for the investigation.Additionally, based on event information the returned iabc was potentially inserted through the sheath other than the supplied sheath in the kit, which can prevent insertion due to inability to pass the iabc into the artery and the iabc may get stuck in sheath or cause vascular damage.As a result, an in-service for the customer is requested to reiterate the importance of the sheath selection.The instructions for use (ifu) states: "sheathed insertion: assemble sheath by inserting dilator into hemostasis sheath introducer.Two sheath introducer/dilator assemblies are supplied in each kit: 1) sheath with sidearm, 2) sheath without sidearm.The physician should select hemostasis sheath introducer or hemostasis device based on patient needs and physician preference.If using sheath with sidearm, flush sidearm with heparinized saline." "note: a catheter one french size smaller than the sheath size is necessary for satisfactory sidearm pressure recording." "although it is recommended to use sheath introducers supplied in the insertion kit, arrow iabs have been qualified for use with other manufacturer's introducers.Follow arrow iab labeling for appropriate sheath selection and review sheath manufacturer's labeling and instructions for use." the bladder thickness was measured at six points with measurements ranging from 0.0068in-0.0074in.The inner diameter of the 9.5fr teflon sheath extrusion distal tip measured 0.126".The inner diameter of the 9.5fr teflon sheath cap hemostasis valve measured 0.171".The inner diameter of the 9fr super arrow-flex (saf) sheath extrusion distal tip measured 0.126".The inner diameter of the 9fr super arrow-flex (saf) sheath cap hemostasis valve measured 0.171".The inner diameter of the 8fr super arrow-flex (saf) sheath extrusion distal tip measured 0.108".The inner diameter of the 8fr super arrow-flex (saf) sheath cap hemostasis valve measured 0.171".The dilator was removed from the 9.5fr teflon sheath without difficulty.No issues were noted to the components.A lab inventory 40cc 8.0fr rediguard iabc (fully wrapped) was inserted through the returned 9.5fr teflon sheath without difficulty.No issues were noted with the returned sheath, including a successful lab inventory iabc insertion through the sheath.A lab inventory 40cc 8.0fr rediguard iabc (fully wrapped) was inserted through the returned 9fr super arrow-flex (saf) sheath without difficulty.No issues were noted with the returned sheath, including a successful lab inventory iabc insertion through the sheath.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times.The one-way valve connected to the short driveline tubing and a negative vacuum was pulled on the returned iabc.While maintaining the pressure, the iabc was removed from the original tray with minimal force.Upon removal of the iabc from the tray, the iabc distal tip was noted within the bladder.Additionally, two kinks to the iabc central lumen were noted at approximately 5cm and 5.6cm from the iabc distal tip.This damage indicates that the iabc was potentially attempted to be reinserted within the original tray after the initial removal of the iabc from the tray.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested.No leaks were detected.Full inflation was achieved.The device passed the leak test.The iabc was connected to an iabp with the returned 40cc inflation driveline tubing.The iabc was inserted into the "t" tube and 100mmhg backpressure was applied.The iabc was pumped for a minimum of 30 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.The balloon pressure waveform (bpw) was normal.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 5cm and 5.6cm from the iabc distal tip, which are the locations of the previously noted kinks.The guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 79.5cm and 80cm from the iabc luer, which are the locations of the previously noted kinks.The guidewire was able to advance through the central lumen.No blood or debris was noted.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint that the "balloon could not be negotiate through the sheath" is not able to be confirmed.No issues were noted to the returned sheaths and all returned sheaths appeared unused; the sheath in question was potentially not returned.Additionally, the returned intra-aortic balloon catheter (iabc) was noted unused and returned within the original packaging.During removal and inspection of the iab, numerous kinks were noted to the central lumen.It could not be confidently determined how this damage occurred to the returned iabc.The iabc bladder membrane passed dimensional and functional inspection.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.An in-service has been requested to review the instructions for use (ifu) with the customer to reiterate the importance of the sheath selection.

Event Description

It was reported that the intra-aortic balloon (iab) could not be negotiate through the sheath.The iab was tried from both right and left femoral artery.As a result, a new iab was used.There was no report of patient complications.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville, MA 27560
• MDR Report Key: 10828969
• MDR Text Key: 215902149
• Report Number: 3010532612-2020-00331
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F17L0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 12/11/2020; 01/20/2023
• Supplement Dates FDA Received: 12/15/2020; 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1