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

Model Number M0063901050

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

(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 Description

It was reported to boston scientific corporation that a zero tip stone retrieval baket was to be used in a procedure on (b)(6) 2020.According to the complainant, during preparation, a black stain was noted on the "pb".No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

H10 block h6: device code 2944 captures the reportable event of "black stain was noted on the pb".Block h10: the zero tip basket was returned in its original unopened pouch.Visual analysis found the heat seal ran throughout the entire length of the pouch without any breakage.Black stains was observed in the front section of the pouch outside the sterile area.No other issues were identified.Based on all available information, it is most likely that handling and manipulation of the device during transport/storage contributed to the observed issue.It is also probable that how the device was handled and manipulated during the processes of shipping/receiving, storage, or packing inside of the generic bag could have contributed to the observed issue.Therefore, the most probable root cause is cause traced to transport/storage.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 Description

It was reported to boston scientific corporation that a zero tip stone retrieval baket was to be used in a procedure on (b)(6) 2020.According to the complainant, during preparation, a black stain was noted on the "pb".No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: ZERO TIP
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9929721
• MDR Text Key: 191422751
• Report Number: 3005099803-2020-01513
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: 08714729469643
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 0025021773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 05/21/2020
• Supplement Dates FDA Received: 06/16/2020
• Patient Sequence Number: 1