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

Catalog Number IAB-S730C

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while in the cath lab the medical doctor was not able to "regurge" the balloon.So, the medical doctor requested another iab and used the new iab successfully.Additional information received 11/01/2016.The iab was inserted into the patient via the femoral artery.After not being able to "regurge" the balloon the md removed the iab and sheath.Another iab was prepped inserted via the same insertion site.There was a 10 minute delay / interruption in iabp therapy.There was no harmful outcome to the patient.

Manufacturer Narrative

Qn#(b)(4).Evaluation: the reported complaint of unable to aspirate/flush central lumen is not confirmed.However, the device was found kinked and had numerous bends to the central lumen which may have caused the reported complaint.The root cause of the kink/bends is undetermined.The ifu states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage." 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.Other remarks: conclusion: the reported complaint of unable to aspirate/flush central lumen is not confirmed.However, the device was found kinked and had numerous bends to the central lumen which may have caused the reported complaint.The root cause of the kink/bends is undetermined.

Event Description

It was reported that while in the cath lab the md was not able to "regurge" the balloon.So, the md requested another iab and used the new iab successfully.Additional information received 11/01/2016: the iab was inserted into the patient via the femoral artery.After not being able to "regurge" the balloon the md removed the iab and sheath.Another iab was prepped inserted via the same insertion site.There was a 10 minute delay / interruption in iabp therapy.There was no harmful outcome to the patient.

• Brand Name: REDIGUARD IAB: 7FR 30CC
• 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: 6123455
• MDR Text Key: 60745157
• Report Number: 1219856-2016-00269
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F16D0031
• Other Device ID Number: 00801902002686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2016
• 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