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 07/02/2015

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a right ureteroscopy and stone fragmentation and stent change procedure on (b)(6) 2015.According to the complainant, when the device was removed from the packaging, it was observed that there was a crack in the blue coating mid-way along the shaft distal to the coil.Reportedly, the crack in the blue coating prevented the basket from opening and closing.The device was not used and the procedure was completed with another stone cone device.Additionally, no damage was noted to the packaging prior to use.The patient¿s condition at the conclusion of the procedure was reported to be ¿stable¿.

Manufacturer Narrative

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.

Manufacturer Narrative

A visual analysis of the returned device revealed that the blue sheath is separated into two pieces approximately 17 cm from the proximal end.The blue sheath is accordioned below the separation on the proximal end preventing the device from closing.The evaluation concluded that the blue sheath was separated into two pieces.Since the event was caused by handling of the device during preparation, 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 during a right ureteroscopy and stone fragmentation and stent change procedure on (b)(4) 2015.According to the complainant, when the device was removed from the packaging, it was observed that there was a crack in the blue coating mid-way along the shaft distal to the coil.Reportedly, the crack in the blue coating prevented the basket from opening and closing.The device was not used and the procedure was completed with another stone cone device.Additionally, no damage was noted to the packaging prior to use.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: 4965611
• MDR Text Key: 6334694
• Report Number: 3005099803-2015-02196
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2015

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: 10/31/2017
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: D23880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• 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