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

Catalog Number IAB-05840-LWS

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Congestive Heart Failure (1783); Low Cardiac Output (2501)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).See also mdr #1219856-2017-00059.

Event Description

It was reported that the event involved a patient of 70 inches in height.The intra-aortic balloon (iab) was inserted via sheath into the patient's right axillary artery on (b)(6) 2017 in the operating room (or).That evening, during therapy post insertion, the balloon ruptured and was removed by the medical doctor (md).The sheath remained in place.The patient was taken to cath lab on (b)(6) 2017 and a new iab was inserted via sheath.The length of time in use prior to event was less than 19 hours.There was an interruption in intra-aortic balloon pump (iabp) therapy for less than 11 hours.There was no reported patient death, injury or complications.

Manufacturer Narrative

(b)(4).Teleflex received the device for analysis.The reported complaint of blood in helium pathway is confirmed.The iab bladder has a full thickness abrasion which allowed blood to enter the iab.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.No further action required.A device history report review was performed and it did not reveal any manufacturing related issues.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.Other remarks: please refer to mdr #1219856-2017-00059/(b)(4) related to this complaint.

Event Description

It was reported that the event involved a patient of (b)(6) inches in height.The intra-aortic balloon (iab) was inserted via sheath into the patient's right axillary artery on (b)(6) 2017 in the operating room (or).That evening, during therapy post insertion, the balloon ruptured and was removed by the medical doctor (md).The sheath remained in place.The patient was taken to cath lab on (b)(6) 2017 and a new iab was inserted via sheath.The length of time in use prior to event was less than 19 hours.There was an interruption in intra-aortic balloon pump (iabp) therapy for less than 11 hours.There was no reported patient death, injury or complications.

• 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: 6437359
• MDR Text Key: 71000102
• Report Number: 1219856-2017-00058
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16J0023
• Other Device ID Number: 00801802007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• 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
• Patient Age: 60 YR
• Patient Weight: 88