MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06840-U

Device Problems Device Alarm System (1012); Crack (1135); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was that when the medical doctor opened the package he found the catheter with a little kink.The kink caused difficulty when the intra-aortic balloon (iab) was inserted.After insertion, the catheter worked for 2-3 minutes then the intra-aortic balloon pump (iabp) alarmed.The doctor then pull the catheter out of the patient and found the central lumen cracked.As a result, the iab was removed and replaced with a new iab successfully.There was no reported death or serious injury.Patient outcome: patient in good condition.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint that the iab is kinked is confirmed.The product was not returned for investigation; however, based on the pictures provided with the complaint report, the central lumen appears kinked near the bifurcate of the iab.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 risks.This issue will be monitored for any developing trends.No further action required at this time.

Event Description

It was that when the medical doctor opened the package he found the catheter with a little kink.The kink caused difficulty when the intra-aortic balloon (iab) was inserted.After insertion, the catheter worked for 2-3 minutes then the intra-aortic balloon pump (iabp) alarmed.The doctor then pull the catheter out of the patient and found the central lumen cracked.As a result, the iab was removed and replaced with a new iab successfully.There was no reported death or serious injury.Patient outcome: patient in good condition.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 6890048
• MDR Text Key: 87216611
• Report Number: 1219856-2017-00212
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F17B0027
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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
• Patient Age: 67 YR