MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06830-U

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), the arterial sheath was inserted successfully, but the spring-wire guide (swg) was not delivered smoothly.The angle of the sheath was adjusted, but the swg was still not delivered smoothly.As a result, the swg and the catheter were inserted slowly.The process of usage and removal of the sheath were successful.Patient outcome reported as fine.There was no report of patient death.

Manufacturer Narrative

(b)(4).For reported complaint involving the same patient and device see mdr #3010532612-2019-00119 and (b)(4).Teleflex received the device for investigation.The reported complaint that the "spring-wire guide was not delivered smoothly" is confirmed.A broken central lumen was noted on the returned iab during the complaint investigation, and this is consistent with guidewire insertion difficulty.The root cause of the broken central lumen is undetermined but a potential cause is a result of improper customer handling during preparation and insertion of the iab.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.The reported complaint will be monitored for any developing trends.An in-service will be performed to reiterate the ifu to the customer.Other remarks: additional information received.There was no reported difficulty with insertion of the spring wire guide.

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), the arterial sheath was inserted successfully, but the spring-wire guide (swg) was not delivered smoothly.The angle of the sheath was adjusted, but the swg was still not delivered smoothly.As a result, the swg and the catheter were inserted slowly.The process of usage and removal of the sheath were successful.Patient outcome reported as fine.There was no report of patient death.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8496900
• MDR Text Key: 141376938
• Report Number: 3010532612-2019-00108
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• Combination Product (y/n): N
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F17M0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 130