MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) INJECTION GOLD PROBE¿; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00560150

Device Problem Material Separation (1562)

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

Event Date 12/03/2015

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 medwatch will be filed.

Event Description

Note: this report pertains to one of two devices used during a procedure.Refer to the manufacturer report # 3005099803-2015-03719 for the first injection gold probe and manufacturer report # 3005099803-2015-03720 for the second injection gold probe.It was reported to boston scientific corporation that two injection gold probes were used in the patient's colon during a colonoscopy procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the first injection gold probe was removed from the patient and the scope for cleaning.During cleaning, it was found that the distal tip of the device was got separated and was missing.A second injection gold probe was used; however, during the procedure, a part of the distal tip of the probe had detached inside the patient.Reportedly, the patient was sent for x-ray and the missing tip was found in the patient's duodenum.The procedure was completed with another injection gold probe.Despite numerous attempts boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available a supplemental report will be submitted.

Manufacturer Narrative

Visual analysis of the returned injection gold probe¿ revealed that the ceramic distal tip was detached and was not returned.Further evaluation found the needle was kinked and exposed; and the catheter was kinked near the handle.A transversal cut applied to the catheter revealed tread marks and the device has presence of glue and the internal electrical wires have evidence of burned in distal section.The complaint was confirmed.The investigation concluded that this complaint is associated with a product that meets design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.Therefore, the most probable root cause classification for the reported failure is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

Note: this report pertains to one of two devices used during a procedure.Refer to the manufacturer report # 3005099803-2015-03719 for the first injection gold probe¿ and manufacturer report # 3005099803-2015-03720 for the second injection gold probe¿.It was reported to boston scientific corporation that two injection gold probes were used in the patient¿s colon during a colonoscopy procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the first injection gold probe was removed from the patient and the scope for cleaning.During cleaning, it was found that the distal tip of the device was got separated and was missing.A second injection gold probe was used; however, during the procedure, a part of the distal tip of the probe had detached inside the patient.Reportedly, the patient was sent for x-ray and the missing tip was found in the patient¿s duodenum.The procedure was completed with another injection gold probe¿.Despite numerous attempts boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available a supplemental report will be submitted.

• Brand Name: INJECTION GOLD PROBE¿
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5332129
• MDR Text Key: 34589569
• Report Number: 3005099803-2015-03720
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K961349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2017
• Device Model Number: M00560150
• Device Catalogue Number: 6015
• Device Lot Number: 18102688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• 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