MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MICROKNIFE XL; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00532810

Device Problems Contamination (1120); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(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

It was reported to boston scientific corporation that a microknife xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during preparation, the nurse found that the package of the device was damaged and could not be used.Reportedly, the sterile barrier was compromised.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Correction - block g1 (mfr site facility name): corrected from boston scientific de costa rica s.R.L.To boston scientific corporation.Block e1 (initial reporter address 1): (b)(6).Block h6 (device codes): problem code 1120 captures the reportable event of device not sterile.Block h10: the returned microknife xl was analyzed, and a visual evaluation noted that the pouch was wrinkled and the mylar section above the label was damaged, exposing the device and compromising the sterile barrier.No other issue with the device were noted.The reported event was confirmed.Based on the physical condition of the device the failure found could had been generated by the way the device was stored and manipulated.Therefore, the most probable root cause of this complaint is cause traced to transport/storage.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a microknife xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during preparation, the nurse found that the package of the device was damaged and could not be used.Reportedly, the sterile barrier was compromised.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: MICROKNIFE XL
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10336521
• MDR Text Key: 200861530
• Report Number: 3005099803-2020-02964
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: 08714729172017
• Combination Product (y/n): N
• PMA/PMN Number: K973826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2021
• Device Model Number: M00532810
• Device Catalogue Number: 3281
• Device Lot Number: 0023654185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 56