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

Catalog Number IAB-06830-U

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Blood Loss (2597)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For reported complaint involving the same patient and device see mdr #3010532612-2019-00108 and (b)(4).

Event Description

It was reported that after intra-aortic balloon (iab) treatment, the sheath was removed successfully.The wall of the sheath was found damaged.The patient outcome was reported as fine.Additional information obtained.There was no report of removal difficulty during the sheath removal process.The sheath was found broken after finishing the treatment.It was also reported that the patient was injured.The patient lost much blood (about 200ml) as the un-smooth insertion.Additional information obtained.There were no adverse events from the blood loss.The patient did not require a blood transfusion, blood pressure did not decline and no reported increase in chest pain.There was no report of patient death.

Event Description

It was reported that after intra-aortic balloon (iab) treatment, the sheath was removed successfully.The wall of the sheath was found damaged.The patient outcome was reported as fine.Additional information obtained.There was no report of removal difficulty during the sheath removal process.The sheath was found b roken after finishing the treatment.It was also reported that the patient was injured.The patient lost much blood (about 200ml) as the un-smooth insertion.Additional information obtained.There were no adverse events from the blood loss.The patient did not require a blood transfusion, blood pressure did not decline and no reported increase in chest pain.There was no report of patient death.

Manufacturer Narrative

(b)(4).For reported complaint involving the same patient and device see mdr #3010532612-2019-00108 and tc #1900067280.Teleflex received the device for investigation.The reported complaint that the "wall of the sheath was damage" is confirmed.Upon return, a buckling of the sheath wall and damage was noted on the teflon sheath.The root cause of the damaged teflon sheath is undetermined but a potential cause is a result of improper customer handling during insertion or removal of the teflon sheath.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:.

• 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: 8497258
• MDR Text Key: 141386597
• Report Number: 3010532612-2019-00119
• 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?: Yes
• Is this a Product Problem Report?: No
• 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