MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000254

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by a teleflex sales rep.(sr) as told by (b)(6) (hospital staff) "placed on (b)(6) 2021 at 1915 on (b)(6) 1856 helium loss while moving the patient no blood in tubing.On (b)(6) 2021 at 2123 had trigger loss alarm and flushed the side port and it resolved.On (b)(6) 2021 at 8:07 helium loss 2 alarm with no blood in the tubing the nurse restarted the pump and saw the blood immediately in the tubing, clamped the tubing, and turned off pump.Intra-aortic balloon (iab) was removed 8:21 from ccu attending showing signs of stroke." there was no alleged contribution of the device malfunction to the reported stroke.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the catheter which allowed blood to enter the helium pathway.The root cause of the broken fiber 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 risk.This will be monitored for any developing trends.

Event Description

It was reported by a teleflex sales rep.(sr) as told by (b)(6) (hospital staff) "placed on (b)(6) 2021 at 1915 on (b)(6) 1856 helium loss while moving the patient no blood in tubing.On (b)(6) 2021 at 2123 had trigger loss alarm and flushed the side port and it resolved.On (b)(6)2021 at 8:07 helium loss 2 alarm with no blood in the tubing the nurse restarted the pump and saw the blood immediately in the tubing, clamped the tubing, and turned off pump.Intra-aortic balloon (iab) was removed 8:21 from ccu attending showing signs of stroke." there was no alleged contribution of the device malfunction to the reported stroke.

• Brand Name: ARROW
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12078846
• MDR Text Key: 258895353
• Report Number: 3010532612-2021-00167
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F21D0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 60