MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number M0068403910

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however 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 on (b)(6) 2017 that a flexiva 200 laser fiber was procured for use in a procedure performed on (b)(6) 2017.According to the complainant, during unpacking and outside the patient, the laser fiber was noted to be bent.The procedure was completed with another flexiva 200 laser fiber.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

One flexiva 200 laser fiber was received for evaluation.Visual examination revealed that the exposed glass fiber tip measured approximately 3.5 mm and appeared unused.Examination under magnification confirmed that the tip was unused.The fiber was returned broken into four pieces.The first piece measured approximately 49.5 cm from the top of the connector to the break.The second piece measured approximately 20 cm from break to break.The third piece measured approximately 82.5 cm from break to break and the fourth piece measured approximately 162.5 cm from the break and includes the entire distal tip.The condition of the returned device confirms the event.Therefore, a review and analysis of all available information indicated that the root cause is supplier manufacture.The product likely failed to meet the specifications due to the manufacturing process at the supplier site, and there is an investigation in place to address this issue.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a flexiva 200 laser fiber was procured for use in a procedure performed on (b)(6) 2017.According to the complainant, during unpacking and outside the patient, the laser fiber was noted to be bent.The procedure was completed with another flexiva 200 laser fiber.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• Brand Name: FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6945073
• MDR Text Key: 90290977
• Report Number: 3005099803-2017-03068
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 08714729808145
• UDI-Public: 08714729808145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2020
• Device Model Number: M0068403910
• Device Catalogue Number: 840-391
• Device Lot Number: 0000004972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2017
• 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