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

Catalog Number IAB-06840-U

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For related complaint see mdr #3010532612-2018-00249 and tc #(b)(4).

Event Description

It was reported that on the intra-aortic balloon (iab) "during insertion the doctor inserted the guidewire it was not able to cross over the wire.They use of a second guidewire, though it was noted blood comes oozing out near the helium post".Another, iab was used on the patient.There was no report of patient death, serious injury or complications.

Manufacturer Narrative

(b)(4) for related complaint see mdr #3010532612-2018-00249 and (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of tight over guidewire is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.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.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that on the intra-aortic balloon (iab) "during insertion the doctor inserted the guidewire it was not able to cross over the wire.They use of a second guidewire, though it was noted blood comes oozing out near the helium post".Another, iab was used on the patient.There was no report of patient death, serious injury or complications.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7702905
• MDR Text Key: 114544919
• Report Number: 3010532612-2018-00229
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• 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: 06/28/2018

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: 08/31/2019
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F17J0014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 08/23/2018
• Supplement Dates FDA Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR