MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; INTRA- AORTIC BALLOON FIBER OPTIC

Catalog Number IAB-05840-LWS

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event involved a patient in the cath lab the iab was inserted and soon after putting in the body the catheter clotted.According to the customer "it would not work at all." as a result the iab was removed and replaced successfully.There was a delay in iabp therapy however no harm caused to the patient.There was no reported patient death, injury or complications.The patient outcome is listed as "survived".

Manufacturer Narrative

(b)(4).The sample was return the one-way valve was connected and tethered to the short driveline tubing.The iab hemostasis cuff was connected to the cathgard.The bladder was loosely wrapped.Dried blood was noted on the exterior of the bladder, outer lumen, cathgard, bifurcate and one-way valve.The fos connector and cal key were examined.The gray fos connecter was recessed in the housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined and no damage was noted.The cal key was intact.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times.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.The reported complaint of central lumen occluded is confirmed.Initially the central lumen failed aspiration and flush testing.Upon inserting the guidewire, blood exited the central lumen.Aspiration and flushing were successfully completed after the guidewire test.The blood built up in the central lumen may have occurred from not maintaining a patency of the arterial line.

Event Description

It was reported that the event involved a patient in the cath lab the iab was inserted and soon after putting in the body the catheter clotted.According to the customer "it would not work at all." as a result the iab was removed and replaced successfully.There was a delay in iabp therapy however no harm caused to the patient.There was no reported patient death, injury or complications.The patient outcome is listed as "survived".

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• 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: 5990094
• MDR Text Key: 56018617
• Report Number: 1219856-2016-00212
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2016

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: 07/31/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16G0019
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2016
• 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