MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

Event site postal code (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

It was reported during insertion of the intra-aortic balloon (iab), the practitioner opened the iab but found the sheath was widened after using the dilator and an introducer dilator was not included.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely folded and still within the t-handle w/retainers with no visible blood on the exterior of the catheter.The extender tubing, sheath, introducer dilator, guidewire, pressure tubing, one-way valve, syringe, angiographic needle and 3-way stopcock were also returned.The sheath was observed to be kinked at approximately 11.4cm from the sheath tip.Additionally, the returned dilator was also observed to be warped/damaged along its length.A visual evaluation determined that the products returned do not match the products from the provided photos.The returned sheath was measured and found to be within specifications.Given that the insertion kit pouch from the provided photos was opened and does not match the actual products returned, we are unable to conclusively determine which products were missing from the pouch or when they were initially packaged since it was returned opened.The evaluation did not confirm the reported problem.We are unable to mimic the clinical settings.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint #: (b)(4).

Event Description

It was reported during insertion of the intra-aortic balloon(iab), the practitioner opened the iab but found the sheath was widened after using the dilator and an introducer dilator was not included.There was no reported injury to the patient.

• Brand Name: LINEAR 7.5 FR. 34CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10107405
• MDR Text Key: 196848644
• Report Number: 2248146-2020-00269
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

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: 09/19/2022
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000104732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/01/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1