MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TIGERPAW SYSTEM III 7C 35MM; STAPLE, IMPLANTABLE

Model Number	35MM
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Injury (2348); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complete initial reporter name: (b)(6).Brand name:tigerpaw pro left atrial appendage closure device 35mm.The device will not be returned to the manufacturer to complete an evaluation.If additional information is provided, we will send a supplemental report with our additional findings.Complaint record id #(b)(4).
Event or Problem Description
It was reported that during deployment of the tigerpaw pro (tpp) clip, a loud "crackling" noise was heard.Following deployment, bleeding was observed at the distal, posterior end of the left atrial appendage (laa).The patient was put on on-pump coronary artery bypass.The physician noted that the patient had a low ejection fraction (ef) and required four pledgeted stitches to repair the tear.The physician believes the distal tips of the tpp can/are crushing the distal end of the laa.
Event or Problem Description
It was reported that during deployment of the tigerpaw pro (tpp) clip, a loud "crackling" noise was heard.Following deployment, bleeding was observed at the distal, posterior end of the left atrial appendage (laa).The patient was put on on-pump coronary artery bypass.The physician noted that the patient had a low ejection fraction (ef) and required four pledgeted stitches to repair the tear.The physician believes the distal tips of the tpp can/are crushing the distal end of the laa.
Additional 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.The reported failure have been escalated for further investigation.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).However, based on the excess complaints received for the reported failure, a capa was initiated to investigate the issue.Reference complaint (b)(4) h3 other text : device not returned.

• Brand Name: TIGERPAW SYSTEM III 7C 35MM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 11352817
• Report Number: 2248146-2021-00105
• Device Sequence Number: 11608959
• Product Code: GDW
• UDI-Device Identifier: 10607567510996
• UDI-Public: 10607567510996
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K190884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 35MM
• Device Catalogue Number: 750001099
• Device Lot Number: 92310976
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ON-PUMP CORONARY ARTERY BYPASS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR