MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTATABLE SNARE; SNARE, FLEXIBLE

Model Number M00561821

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a rotatable small oval med stiff snare was prepared for use during a procedure on (b)(6) 2019.According to the complainant, during unpacking, it was noted that the sheath of one unopened device has something like dirt attached to it.Reportedly, the device was not used.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available, a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that a rotatable small oval med stiff snare was prepared for use during a procedure on (b)(6) 2019.According to the complainant, during unpacking, it was noted that the sheath of one unopened device has something like dirt attached to it.Reportedly, the device was not used.***additional information received on june 25, 2019*** the dirt that was observed on the tip side of the sheath looked like a very small paint.

Manufacturer Narrative

Block e1: the initial reporter address is (b)(6).Block h6: problem code 2944 captures the reportable event of foreign material present in device.Block h10: investigation results visual analysis of the returned device revealed that the device was received on sealed pouch and it has a blue particle inside the pouch.Based on the external support form attached, no components or chemicals during manufacturing procedures could generate blue particles.There is an operation in which the unit must be clean using isopropyl alcohol to remove any foreign matter from the device and is inspected to verify the absence of foreign matter.Then, process controls are in place to inspect the unit when it is packed inside the pouch looking for cosmetic defect or foreign matter.There was no evidence that he foreign matter was generated during manufacturing process.Based on the information available and the analysis performed, the most probable root cause classification is caused traced to transport/storage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Manufacturer Narrative

Block e1: the initial reporter address is (b)(6).Block h6: problem code 2944 captures the reportable event of foreign material present in device.Block h10: 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.Block h11: blocks b5, d10 (device avail for evaluation, returned to manufacturer date), h2, h3 (device eval by manufacturer, device not eval by mfr code, device return to manufacturer) and h10 have been updated based on the additional information received on june 25, 2019.

Event Description

It was reported to boston scientific corporation that a rotatable small oval med stiff snare was prepared for use during a procedure on (b)(6) 2019.According to the complainant, during unpacking, it was noted that the sheath of one unopened device has something like dirt attached to it.Reportedly, the device was not used.Additional information received on june 25, 2019: the dirt that was observed on the tip side of the sheath looked like a very small paint.

• Brand Name: ROTATABLE SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8510450
• MDR Text Key: 141799688
• Report Number: 3005099803-2019-01866
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: 08714729283980
• Combination Product (y/n): N
• PMA/PMN Number: K160637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2021
• Device Model Number: M00561821
• Device Catalogue Number: 6182
• Device Lot Number: 0023042757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1