MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL; DISLODGER, STONE, FLEXIBLE

Model Number M0063903100

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2015

Event Type  malfunction  

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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the left ureteropelvic junction during an endoscopic lithotripsy procedure performed on (b)(6) 2015.According to the complainant, during preparation, the physician tested the device by advancing the sheath over the coil.However, the coil closed and opened with resistance.The physician applied force that resulted to peeling of the tip coating.The procedure was completed with another of the same device.Additionally, no damage was noted to the packaging prior to use.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "stable.".

Manufacturer Narrative

A visual analysis of the returned device revealed that the signs of the coating peeling were not evident, and the peeled off piece of coating was not returned.The peeled piece of coating was most likely too thin to show up as a skive mark on the returned device, therefore making it unidentifiable.The device opens and closes with high resistance.Review and analysis of all available information indicates that the device was damaged before use.Therefore, the most probable root cause is handling damage.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no similar complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the left ureteropelvic junction during an endoscopic lithotripsy procedure performed on (b)(6) 2015.According to the complainant, during preparation, the physician tested the device by advancing the sheath over the coil.However, the coil closed and opened with resistance.The physician applied force that resulted to peeling of the tip coating.The procedure was completed with another of the same device.Additionally, no damage was noted to the packaging prior to use.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "stable".

• Brand Name: STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ACCELLENT ENDOSCOPY JUAREZ; 31c butterfield trail; el paso TX 79906
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5202633
• MDR Text Key: 30457953
• Report Number: 3005099803-2015-03013
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

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: 11/30/2016
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: B91146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 62