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 Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The registered nurse called to report that an intra-aortic balloon (iab) would not advance over the guidewire.The rn stated that as they fed it over the wire it seemed like the guidewire would get stuck about six inches into the iab.He stated that it seemed like there was something plugging the lumen in the catheter.As a result, a different iab was used with no difficulty.There was no reported death or serious injury and no medical/surgical intervention required.There was a reported delay in therapy but no harm caused to the patient.Patient was stable on the pump.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of tight over guidewire is confirmed.Although, the actual root cause could not be determined a kink on the iab central lumen was confirmed during functional testing, and as a result, the guidewire was unable to freely advance through the central lumen.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.This issue will be monitored for developing trends.

Event Description

The rn called to report that an intra-aortic balloon (iab) would not advance over the guidewire.The rn stated that as they fed it over the wire it seemed like the guidewire would get stuck about six inches into the iab.He stated that it seemed like there was something plugging the lumen in the catheter.As a result, a different iab was used with no difficulty.There was no reported death or serious injury and no medical/surgical intervention required.There was a reported delay in therapy but no harm caused to the patient.Patient was stable on the pump.

• 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: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6726113
• MDR Text Key: 80493733
• Report Number: 1219856-2017-00152
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K02162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17E0006
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2017
• 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