MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000262

Device Problem Entrapment of Device (1212)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2022

Event Type  Injury  

Event Description

It was reported that while inserting the balloon, it got stuck in the sheath and was unable to advance further.As a result, a different balloon was inserted on the other side.Patient condition was not provided, if additional information is received at a later date, the complaint file will be updated accordingly.

Manufacturer Narrative

(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.

Manufacturer Narrative

Qn# (b)(4).The product was not returned for investigation.The reported complaint for iab 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.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 revised risk.This will be monitored for any developing trends.

Event Description

It was reported that while inserting the balloon, it got stuck in the sheath and was unable to advance further.As a result, a different balloon was inserted on the other side.Patient condition was not provided, if additional information is received at a later date, the complaint file will be updated accordingly.

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 (b)(6).Additional information obtained from a teleflex representative indicates the returned sample is the correct iabc for this complaint.Returned for investigation was a 30cc 7.0fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that does not match the serial number on the returned iabc.The sample was returned in a cardboard box and was loosely packed within a sealed pouch and an original packaging box.Returned with the sample was supplied 30cc inflation driveline tubing and short/long arterial pressure tubing; no damage or abnormalities were noted to the returned components.No damage or abnormalities were noted to the returned packaging tray.Upon return, it was noted that the iabc was fully advanced through the correct 8fr super arrow-flex (saf) sheath and the sheath was noted on the iabc outer lumen area.The distal end of the saf sheath was noted at approximately 25cm from the iabc distal tip.The entire sheath was visually inspected; no damage or abnormalities were noted to the sheath body, hub, and tip.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Numerous kinks to the iabc central lumen were noted at approximately 20.3cm, 20.7cm, 21cm, 23cm, 23.9cm, and 24.5cm from the iabc distal tip.Spots of dried blood were noted on the exterior surfaces of the returned sample.No blood was noted within the helium pathway.The bladder thickness was measured at six points.The returned iabc had previously been fully advanced through the correct 8fr super arrow-flex (saf) sheath, upon receipt of the sample.The returned sheath moved freely on the catheter body/outer lumen.Upon return, the bladder was fully unwrapped.As a result of the returned state, no attempts could be made to insert the returned iabc through another lab inventory 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 iabc central lumen was successfully 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.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Re sistance was noted at approximately 20.2cm, 20.8cm, 21cm, 23.2cm, 24.1cm, and 24.6cm 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 gui dewire was front loaded through the iabc luer.Resistance was noted at approximately 60.4cm, 60.9cm, 61.7cm, 63.9cm, 64.2cm, and 64.7cm 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 of iab catheter stuck in sheath is confirmed based on the returned state of the sample.Numerous kinks to the central lumen were noted upon return.The returned intra-aortic balloon catheter (iabc) had previously been fully advanced through the correct sheath.No issues were found with the sheath and there is no evidence of the sheath being stuck or damaged.The returned iabc bladder membrane passed dimensional and functional inspection.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the kinked central lumen.The root cause of the kinks is undetermined.A most probable potential cause is customer handling.No further action required at this time.This will be monitored for any developing trends.

Event Description

It was reported that while inserting the balloon, it got stuck in the sheath and was unable to advance further.As a result, a different balloon was inserted on the other side.Patient condition was not provided, if additional information is received at a later date, the complaint file will be updated accordingly.

• Brand Name: REDIGUARD IAB: 7FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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: 14414104
• MDR Text Key: 291801997
• Report Number: 3010532612-2022-00175
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: 00801902002686
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: IPN000262
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F20D0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2020
• 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
• Patient Age: 66 YR
• Patient Weight: 50 KG