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

Model Number IPN000263

Device Problems Difficult to Insert (1316); Failure to Advance (2524)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that the introducer lumen is incompatible with the diameter of the intra-aortic balloon (iab).The iab has not advanced to reach the desired location, difficulty in inserting the iab in the patient.As a result, the physician asked the hospital's pharmacy for an extra wire introducer from another manufacturer to complete the procedure.A new iab was inserted into the patient using the same insertion site.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the introducer lumen is incompatible with the diameter of the intra-aortic balloon (iab).The iab has not advanced to reach the desired location, difficulty in inserting the iab in the patient.As a result, the physician asked the hospital's pharmacy for an extra wire introducer from another manufacturer to complete the procedure.A new iab was inserted into the patient using the same insertion site.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No part has returned to teleflex chelmsford for investigation.The reported complaint of insertion difficulty 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 revived risk.This will be monitored for any developing trends.

Manufacturer Narrative

(b)(4).A complaint sample was returned to our manufacturing site for evaluation.The device was reviewed as part of our investigation.Returned for investigation was one 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) without the original packaging box.The sample was returned in a cardboard box and was loosely packed in a clear plastic bag.Returned with the sample were non-teleflex accessories including 2 guidewires, ap tubing, and helium driveline tubing.No sheath was returned.The one-way valve was tethered and connected to the short driveline tubing.The iabc bladder was fully unwrapped.The distal portion of the bladder appeared to be manually rewrapped, the rewrapped section measured approximately 3.0cm.5 kinks/bends to the iabc central lumen were noted from approximately 7.2cm and 11.5cm from the iabc distal tip.Blood was noted on the exterior surfaces of the returned iabc; no blood was noted within the helium pathway.During functional inspection, the bladder thickness was measured at six points with measurements ranging from 0.0071in-0.0076in and was within specifications of process documents.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 according to quality system document.An attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed due to the previously noted kinks to the central lumen.Immediate push back on the syringe plunger was experienced.The iabc was leak tested in accordance with testing methods from manufacturing procedure.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.The guidewire could not advance at approximately 7.2cm from the iabc distal tip, which is the location of the previously noted kinks.A speck of blood was noted on the guidewire after removal.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 73.6cm from the iabc luer, which is the location of the previously noted kinks.A speck of blood was noted on the guidewire after removal.A device history record (dhr) review was conducted for the lot number with no relevant findings.However, the specifications were not met during the complaint investigation due to the kinked/bent central lumen.The root cause of the kinked/bent central lumen is undetermined.A most probable potential cause is customer handling.This will be monitored for any developing trends.

Event Description

It was reported that the introducer lumen is incompatible with the diameter of the intra-aortic balloon (iab).The iab has not advanced to reach the desired location, difficulty in inserting the iab in the patient.As a result, the physician asked the hospital's pharmacy for an extra wire introducer from another manufacturer to complete the procedure.A new iab was inserted into the patient using the same insertion site.There was no report of patient complications, serious injury or death.

• 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: marling heaton ; 3015 carrington mill blvd; morrisville, MA 27560
• MDR Report Key: 10852956
• MDR Text Key: 217118392
• Report Number: 3010532612-2020-00347
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F20B0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/23/2020; 01/19/2023
• Supplement Dates FDA Received: 12/23/2020; 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2020
• 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: 39 YR
• Patient Sex: Male