MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) RX NEEDLE KNIFE XL; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00545840

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

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 microknife rx 3l needle knife was used in the papilla during an endoscopic cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the microknife rx needle detached from the catheter and was stuck in the patient's papilla.The detached needle was retrieved using a biopsy forceps.The procedure was completed with another microknife rx 3l needle knife.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Visual evaluation of the returned device found that the cutting wire was melted and blackened.In addition, tip end was blackened and the working length was twisted.The complaint was consistent with the reported event of needle detached.It is most likely that a peak of voltage applied during the procedure which could cause the failures noted.Based on all the available/gathered and the condition of the returned unit, the most probable complaint investigation conclusion code will be documented as operational context since due to anatomical/procedural factors encountered during the procedure the performance of the device was limited.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.A labeling review was performed and there is no evidence that the device was not used in accordance with the labeling.

Event Description

It was reported to boston scientific corporation that a microknife rx 3l needle knife was used in the papilla during an endoscopic cholangiopancreatography (ercp) procedure performed on (b)(6), 2017.According to the complainant, during the procedure, the microknife rx needle detached from the catheter and was stuck in the patient's papilla.The detached needle was retrieved using a biopsy forceps.The procedure was completed with another microknife rx 3l needle knife.There were no patient complications reported as a result of this event.

• Brand Name: RX NEEDLE KNIFE XL
• 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: 7160063
• MDR Text Key: 96330175
• Report Number: 3005099803-2017-03812
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729283799
• UDI-Public: 08714729283799
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K973826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2019
• Device Model Number: M00545840
• Device Catalogue Number: 4584
• Device Lot Number: 21082742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2017
• 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 Outcome(s): Required Intervention