MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRICEP; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063701180
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No event date was given, therefore an approximate date of (b)(6) 2018 was used as the event date.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a talon mini- forceps packaging was found damaged on an unknown date.According to the complainant, during review of inventory, it was noticed that the device packaging had punctures in it.There was no patient involved in this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
No event date was given, therefore an approximate date of (b)(6) 2018 was used as the event date.Additional information received on 17sep2018.Updated physicians name and hospital contact number.(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a talon mini- forceps packaging was found damaged on an unknown date.According to the complainant, during review of inventory, it was noticed that the device packaging had punctures in it.There was no patient involved in this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on 17sep2018.The initial reporter stated that the sterility of the device was compromised, and the hole was located in the front of the device packaging.
Additional Manufacturer Narrative
A talon non-grasper device was received still inside its original sealed pouch.The clear plastic pouch was found broken on the side where the label goes placed.It is highly possible that the way in which the device was handled and manipulated during the processes of shipping/receiving and/or storage may have contributed to the failure encountered (pouch broken); the defect found is typically caused due to incorrect manipulation of the product while its transport taking into consideration that the unit was returned totally closed/sealed and inside its original package.Therefore, the investigation conclusion code of this event is "cause traced to transport/storage" since problems traced to the inappropriate transport or storage of the device were detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a talon mini- forceps packaging was found damaged on an unknown date.According to the complainant, during review of inventory, it was noticed that the device packaging had punctures in it.There was no patient involved in this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on 17sep2018.The initial reporter stated that the sterility of the device was compromised, and the hole was located in the front of the device packaging.

• Brand Name: TRICEP
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7881372
• Report Number: 3005099803-2018-60478
• Device Sequence Number: 16621585
• Product Code: FFL
• UDI-Device Identifier: 08714729192220
• UDI-Public: 08714729192220
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2018

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: 06/30/2019
• Device Model Number: M0063701180
• Device Catalogue Number: 63335
• Device Lot Number: 0019327433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 09/17/2018; 10/12/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/02/2018; 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1