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

Catalog Number IAB-05840-LWS

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

Patient Problem Loss Of Pulse (2562)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that an angioplasty was performed on a patient of (b)(6) in height.While in the cath lab an intra-aortic balloon (iab) was placed and the patient was transferred to an outside facility.The iab was noted to have ruptured and it was removed by the intensivist.The iab was not replaced.It was also noted by the rn as documented that the patient had a loss of pedal pulse.The pedal pulse resumed after the iab was removed.It was reported that the patient was transferred to rehab.

Manufacturer Narrative

Qn#(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of blood in the helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.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.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.

Event Description

It was reported that an angioplasty was performed on a patient of 178cm in height.While in the cath lab an intra-aortic balloon (iab) was placed and the patient was transferred to an outside facility.The iab was noted to have ruptured and it was removed by the intensivist.The iab was not replaced.It was also noted by the rn as documented that the patient had a loss of pedal pulse.The pedal pulse resumed after the iab was removed.It was reported that the patient was transferred to rehab.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• 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: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6725714
• MDR Text Key: 80493280
• Report Number: 1219856-2017-00157
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17B0008
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/19/2017
• Supplement Dates Manufacturer Received: 06/23/2017
• Supplement Dates FDA Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• 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
• Patient Age: 56 YR
• Patient Weight: 122