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

Catalog Number IAB-S730C

Device Problem Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sample was discarded.

Event Description

It was reported that while in the cath lab the medical doctor (md) stated that the balloon was not inflating well.As a result the medical doctor (md) used another set to complete the procedure successfully.Additional information received on (b)(6) 2016: 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 all the procedure was conducted according to the instruction for use.The procedure was completed successfully after the catheter set was replaced.The second intra-aortic balloon (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

Qn#(b)(4).Evaluation: the product was not returned for to teleflex for evaluation, therefore, we cannot confirm the reported complaint that the balloon would not inflate properly.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.We will continue to monitor for this reported complaint.

Event Description

It was reported that while in the cath lab the medical doctor (md) stated that the balloon was not inflating well.As a result the medical doctor(md)used another set to complete the procedure successfully.Additional information received on 11/1/16: 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 all the procedure was conducted according to the instruction for use.The procedure was completed successfully after the catheter set was replaced.The second intra-aortic balloon (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: 7FR 30CC
• Type of Device: INTRA-AORTIC BALLOON
• 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: 6124000
• MDR Text Key: 60752144
• Report Number: 1219856-2016-00270
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

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: 08/31/2016
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F14H0011
• Other Device ID Number: 00801902002686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2014
• 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