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

Model Number IPN000263

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For related complaint on the same patient and event see mdr #3010532612-2019-00358 and (b)(4).

Event Description

It was reported that on the intra-aortic balloon (iab) after the spring wire guide (swg) was removed, there was no blood when withdrawing the syringe and the same issue occurred after trying many times.The doctor judge preliminary that the central lumen was blocked.As a result, the catheter was removed and another catheter was not inserted.There was no report of patient death.

Event Description

It was reported that on the intra-aortic balloon (iab) after the spring wire guide (swg) was removed, there was no blood when withdrawing the syringe and the same issue occurred after trying many times.The doctor judge preliminary that the central lumen was blocked.As a result, the catheter was removed and another catheter was not inserted.There was no report of patient death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of central lumen occluded 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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: for related complaint on the same patient and event see mdr #3010532612-2019-00358 and tc # (b)(4).

Manufacturer Narrative

Qn# (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of central lumen occluded 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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: for related complaint on the same patient and event see mdr #3010532612-2019-00358 and tc #(b)(4).The complaint was reopened to investigate the device that was returned to teleflex.The reported complaint of central lumen occluded is not confirmed.During functional testing, no blockage or occlusion was noted.The returned device passed functional test specifications.The root cause of the complaint 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.No further action required at this time.

Event Description

It was reported that on the intra-aortic balloon (iab) after the spring wire guide (swg) was removed, there was no blood when withdrawing the syringe and the same issue occurred after trying many times.The doctor judge preliminary that the central lumen was blocked.As a result, the catheter was removed and another catheter was not inserted.There was no report of patient death.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9137285
• MDR Text Key: 182374998
• Report Number: 3010532612-2019-00347
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• Combination Product (y/n): N
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2019

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: 05/31/2019
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F17E0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 10/29/2019; 03/05/2020
• Supplement Dates FDA Received: 10/30/2019; 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1