MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-S840C

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while in the cath lab the medical doctor (md) stated that during insertion the balloon was "automatically deflating after inflation." as a result, the md used another set to complete the procedure successfully.On (b)(6) 2016 additional information was received.The md properly maintained the vacuum on the balloon and there was nothing special at that time.During the intra-aortic balloon pump (iabp) therapy, the md noticed that the balloon was automatically deflated after inflation.The md removed the failed catheter with sheath together and the procedure was conducted according to the instruction for use.The procedure was completed successfully after the catheter set was replacement.The second iab was inserted via a super-arrow flex sheath into the same insertion site.The length of time prior to the event is 15 minutes.There was a 10 minute delay / interruption in therapy.There was no harmful outcome to the patient.

Manufacturer Narrative

(b)(4).Evaluation: the reported complaint of leak suspected is not confirmed.The device passed functional testing and was pump tested successfully.The root cause of the reported complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex will continue to monitor for similar reported complaints.

Event Description

It was reported that while in the cath lab the medical doctor (md) stated that during insertion the balloon was "automatically deflating after inflation." as a result, the md used another set to complete the procedure successfully.On 11/01/2016, additional information was received.The md properly maintained the vacuum on the balloon and there was nothing special at that time.During the intra-aortic balloon pump (iabp) therapy, the md noticed that the balloon was automatically deflated after inflation.The md removed the failed catheter with sheath together and the procedure was conducted according to the instruction for use.The procedure was completed successfully after the catheter set was replacement.The second iab was inserted via a super-arrow flex sheath into the same insertion site.The length of time prior to the event is 15 minutes.There was a 10 minute delay / interruption in therapy.There was no harmful outcome to the patient.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOOON PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 6123476
• MDR Text Key: 60760708
• Report Number: 1219856-2016-00261
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F14J0011
• Other Device ID Number: 00801902002679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1