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

Model Number	35MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/13/2021
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 physician used pledgeted stitches to stop the bleeding.A separate report has been submitted for the "crackling" noise under mfg report number 2248146-2021-00107.
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 physician used pledgeted stitches to stop the bleeding.A separate report has been submitted for the "crackling" noise under mfg report number 2248146-2021-00107.
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 device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall 24 month product complaint trend data for the period apr-19 to mar-21 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).

• Brand Name: TIGERPAW SYSTEM III 7C 35MM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 11477968
• Report Number: 2248146-2021-00160
• Device Sequence Number: 4602870
• Product Code: GDW
• UDI-Device Identifier: 10607567510996
• UDI-Public: 10607567510996
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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?: No
• 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: 06/23/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 06/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR