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

Catalog Number IAB-05840-LWS

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that an intra-aortic balloon (iab) was inserted into a patient (b)(6).Blood was discovered in the gas line upon insertion.As a result, the iab was removed immediately and a new iab was inserted successfully.Patient outcome: reported as stable.There was a delay in therapy that caused no harm to the patient.No patient complications and no death or serious injury.Medical intervention was not required.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of blood in helium pathway is confirmed.Although, the root cause of the broken fiber is undetermined a puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the iab which allowed blood to enter the helium pathway.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.A nonconformance has been initiated to further investigate the root cause.

Event Description

It was reported that an intra-aortic balloon (iab) was inserted into a patient of (b)(6) in height.Blood was discovered in the gas line upon insertion.As a result, the iab was removed immediately and a new iab was inserted successfully.Patient outcome: reported as stable.There was a delay in therapy that caused no harm to the patient.No patient complications and no death or serious injury.Medical intervention was not required.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6984169
• MDR Text Key: 91078980
• Report Number: 1219856-2017-00246
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K021462
• 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: 10/02/2017

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: 10/31/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18S16K0006
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 11/29/2017
• Supplement Dates FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• 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 Weight: 62