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

Model Number M0063902010

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 medwatch will be filed.

Event Description

Note: this report pertains to one of the three devices that was reported to be received damaged.Refer to manufacturer report number 3005099803-2018-61173 for the first escape basket, 3005099803-2018-61174 for the second escape basket and, 3005099803-2018-61175 for the third escape basket.It was reported to boston scientific corporation that an escape basket was unpacked on an unknown date.According to the complainant, during unpacking, it was noticed that there was a tear in the device packaging.There was no patient or procedure involved.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.

Event Description

Note: this report pertains to one of the three devices that was reported to be received damaged.Refer to manufacturer report number 3005099803-2018-61173 for the first escape basket, and 3005099803-2018-61175 for the third escape basket.It was reported to boston scientific corporation that an escape basket was unpacked on an unknown date.According to the complainant, during unpacking, it was noticed that there was a tear in the device packaging.There was no patient or procedure involved.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.

Manufacturer Narrative

If follow-up, what type: additional information: (lot number), (expiration date), (device manufacture date).An unused escape basket was returned for analysis.A visual inspection of the returned device found that the package was severely damaged in one side and both components (pouch and tray) were torn in one side.Therefore, compromising the seal/sterility of the device.It is most likely that handling and manipulation of the device during transport/storage could have contributed with the encountered damages.The device returned has evidence of excessive manipulation which can lead to cause the damages observed in package.Based on the information available and the analysis performed, the investigation conclusion code for the complaint will be documented as "cause traced to transport/storage" since problems traced to the inappropriate transport or storage of the device.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.

• Brand Name: ESCAPE
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8034984
• MDR Text Key: 126177768
• Report Number: 3005099803-2018-61174
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: 08714729121299
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/15/2021
• Device Model Number: M0063902010
• Device Catalogue Number: 390-201
• Device Lot Number: 0022524322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Date Manufacturer Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1