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	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Brand name: (b)(6) pro left atrial appendage closure device 35mm 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 or Problem Description
It was reported that during the deployment of the tigerpaw pro (tpp) clip, the physician heard the handle/ trigger make a "grinding" noise.Following visual confirmation, it was determined that no bleeding / tear has occurred and all tpp connector barbs were correctly connected.The physician continued and completed the off-pump coronary artery bypass (opcab) procedure with no complications.There was no patient harm or adverse event reported.
Event or Problem Description
It was reported that during the deployment of the tigerpaw pro (tpp) clip, the physician heard the handle/ trigger make a "grinding" noise.Following visual confirmation, it was determined that no bleeding / tear has occurred and all tpp connector barbs were correctly connected.The physician continued and completed the off-pump coronary artery bypass (opcab) procedure with no complications.There was no patient harm or adverse event reported.
Additional 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.Reference complaint (b)(4).
Additional Manufacturer Narrative
The product was returned with traces of blood on the handle, jaws and with signs of usage.The locking bar was in a disengaged position, and the jaw pins were retracted.No fastener was returned.There was no physical damage noted.The jaw rotation, rotational mechanism, resetting, reloading & deployment tests were performed.No mechanical issues or unusual noises were encountered or heard.Furthermore, the laboratory fastener was delivered onto the artificial ostium without difficulty.The evaluation did not confirm the reported noise.However, a clicking sound is expected as the handle lever is squeezed and closed.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).
Event or Problem Description
It was reported that during the deployment of the tigerpaw pro (tpp) clip, the physician heard the handle/ trigger make a "grinding" noise.Following visual confirmation, it was determined that no bleeding / tear has occurred and all tpp connector barbs were correctly connected.The physician continued and completed the off-pump coronary artery bypass (opcab) procedure with no complications.There was no patient harm or adverse event reported.

• 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: 11351954
• Report Number: 2248146-2021-00103
• Device Sequence Number: 14298730
• 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,Followup
• Report Date (Section B): 06/15/2021

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
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/04/2021; 06/15/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/24/2021; 06/15/2021
• 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: OFF-PUMP CORONARY ARTERY BYPASS (OPCAB).
• Patient Age: 49 YR