MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0576-01

Device Problem Defective Component (2292)

Patient Problems Physical Entrapment (2327); Injury (2348)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

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 that during insertion of the intra-aortic balloon(iab) physician attempted to place a 50cc sensation plus iab.During the insertion, the 0.025 wire provided in the insertion kit broke in half while inside patient.The wire was maintained in place with the sheath in the femoral artery.Vascular surgery intervention was required to perform cutdown and retrieve wire from artery.Customer aborted iab insertion procedure and did not attempt another following incident.Patient required emergent cut down procedure to retrieve broken piece of wire from artery.

Event Description

It was reported that during insertion of the intra-aortic balloon(iab) physician attempted to place a 50cc sensation plus iab.During the insertion, the 0.025 wire provided in the insertion kit broke in half while inside patient.The wire was maintained in place with the sheath in the femoral artery.Vascular surgery intervention was required to perform cutdown and retrieve wire from artery.Customer aborted iab insertion procedure and did not attempt another following incident.Patient required emergent cut down procedure to retrieve broken piece of wire from artery.

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).

Manufacturer Narrative

Device evaluation: the product was returned with the membrane completely unfolded and blood found on the exterior of the catheter and between the catheter and the sheath.A kink was observed on the catheter tubing approximately 45.2cm from the iab tip.A break in the inner lumen within the membrane was found approximately 26.2cm from the iab tip.This may have occurred during the reported iab removal from patient.A portion of the guide wire was returned.The portion of the guide wire appears to be a clean break.The guide wire was also found to be bent at the j-tip and proximal end of the wire.The evaluation confirms the reported broken guide wire.We were unable to determine how this may have occurred.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.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint # (b)(4).

Event Description

It was reported that during insertion of the intra-aortic balloon(iab) physician attempted to place a 50cc sensation plus iab.During the insertion, the 0.025 wire provided in the insertion kit broke in half while inside patient.The wire was maintained in place with the sheath in the femoral artery.Vascular surgery intervention was required to perform cutdown and retrieve wire from artery.Customer aborted iab insertion procedure and did not attempt another following incident.Patient required emergent cut down procedure to retrieve broken piece of wire from artery.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 11343946
• MDR Text Key: 232398145
• Report Number: 2248146-2021-00098
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2023
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000129065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 107