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

Catalog Number IAB-05840-LWS

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion while the balloon was being placed into the patient, they noticed that the blue connector was broken.As a result, the device was removed and replaced by another unit.There was no reported patient death, injury or complications.It is unknown if there was a delay/interruption in therapy and if medical/surgical intervention was required.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint that "the blue connector was broken" is confirmed.The gray fos connector was returned with a missing retaining tab and was fully separated from the blue slide housing.Therefore, an fos connection was unable to be established.Although, the root cause of the recessed fos is undetermined this type of damage can occur if the fos connector recesses and the retaining tabs on the gray fos connector break.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.A nonconformance has been initiated to further investigate the cause.

Event Description

It was reported that during insertion while the balloon was being placed into the patient, they noticed that the blue connector was broken.As a result, the device was removed and replaced by another unit.There was no reported patient death, injury or complications.It is unknown if there was a delay/interruption in therapy and if medi cal/surgical intervention was required.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 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: 6820368
• MDR Text Key: 83640741
• Report Number: 1219856-2017-00186
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17C0043
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• 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