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

Catalog Number IAB-04840-U

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Left Ventricular Failure (1948)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The event was described as a catheter fracture.It was reported that a patient of (b)(6) in height in the intensive care unit (icu) had an intra-aortic balloon (iab) placed via the left femoral artery.Blood in the gas line was noted.Difficulty was encountered during removal and therapy was delayed or interrupted for 90 minutes.Catheter was replaced via the same insertion site.Intra-aortic balloon pump alarms that occurred: autofill fail.Length of time in use prior to event: in the same day.There was no reported patient death, injury or complications.

Manufacturer Narrative

(b)(4).Teleflex received the device for evaluation.The reported complaint of blood in helium pathway is confirmed.The iab central lumen was found broken.The broken central lumen allowed blood to enter the helium pathway.From the events details provided, the therapy was successful and the event occurred during iab removal.The actual root cause of the broken central lumen is undetermined but based on the analysis of the returned device, the central lumen break is likely caused from patient movement during the device removal.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 risks.This issue will be monitored for any developing trends.

Event Description

The event was described as a catheter fracture.It was reported that a patient of (b)(6) in height in the intensive care unit (icu) had an intra-aortic balloon (iab) placed via the left femoral artery.Blood in the gas line was noted.Difficulty was encountered during removal and therapy was delayed or interrupted for 90 minutes.Catheter was replaced via the same insertion site.Intra-aortic balloon pump alarms that occurred: autofill fail.Length of time in use prior to event: in the same day.There was no reported patient death, injury or complications.

• Brand Name: NARROWFLEX IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; chelmsford MA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6540435
• MDR Text Key: 74317435
• Report Number: 1219856-2017-00097
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K993966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: IAB-04840-U
• Device Lot Number: 18F16H0016
• Other Device ID Number: 00801902002631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2016
• 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: 76 YR
• Patient Weight: 93