MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-S730C

Device Problem Fluid/Blood Leak (1250)

Patient Problem Injury (2348)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the intra-aortic balloon (iab) was in use, the doctor found blood leakage on the catheter, two weeks after the catheter was inserted into the patient.As a result, the iab was removed by the doctor and a new set was used and inserted in the opposite groin.There was a report of delay in therapy.There was no report of patient complication or serious injury and death.

Event Description

It was reported that when the intra-aortic balloon (iab) was in use, the doctor found blood leakage on the catheter, two weeks after the catheter was inserted into the patient.As a result, the iab was removed by the doctor and a new set was used and inserted in the opposite groin.There was a report of delay in therapy.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab leak suspected 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.

Manufacturer Narrative

Qn# (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab leak suspected 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.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that when the intra-aortic balloon (iab) was in use, the doctor found blood leakage on the catheter, two weeks after the catheter was inserted into the patient.As a result, the iab was removed by the doctor and a new set was used and inserted in the opposite groin.There was a report of delay in therapy.There was no report of patient complication or serious injury and death.

• Brand Name: REDIGUARD IAB: 7FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8475552
• MDR Text Key: 140680763
• Report Number: 3010532612-2019-00082
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: 00801902002686
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F17H0021
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: 04/29/2019; 04/29/2019
• Supplement Dates FDA Received: 05/02/2019; 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 55