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

Model Number M0063901050

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/29/2017

Event Type  Injury  

Manufacturer Narrative

Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 basket was used in a cysto ureteroscopy laser procedure performed on (b)(6) 2017.According to the complainant, during procedure, the basket detached inside the patient and was removed with a grasper.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

A zero tip basket was received for analysis.Visual evaluation found the basket wires had been detached from the splice joint section where they go placed and was not returned.The crimp marks at the splice joint were present indicating the correct assembly of the product during manufacturing.The evaluation concluded that during the procedure excessive manipulation of the device and interaction with the scope or other devices most likely contributed to the failure basket wires detached.During manufacturing process, the product is inspected to detect or avoid defects, however, there is no control in how the devices are handled at the field.Therefore, the most probable root cause of this complaint is "operational context" since it is most likely that due to anatomical and/or procedural factors encountered during the procedure the performance of the product was limited.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.A search of the complaint database revealed that no similar complaints exist for the specified lot.Labeling review was performed and no anomalies were noted.

Event Description

It was reported to boston scientific corporation that a zero tip¿ stone retrieval basket was used in a cysto ureteroscopy laser procedure performed on (b)(6) 2017.According to the complainant, during procedure, the basket detached inside the patient and was removed with a grasper.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.

• Brand Name: ZERO TIP¿
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7485411
• MDR Text Key: 107314689
• Report Number: 3005099803-2018-01376
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2019
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 21470846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention