MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) PULMONARY JAGWIRE¿; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	M00515171
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.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 or Problem Description
It was reported to boston scientific corporation that a pulmonary jagwire guidewire was used during a bronchial balloon dilatation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noticed that the tip of the device peeled.The procedure was completed with another pulmonary jagwire guidewire.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a pulmonary jagwire guidewire was used during a bronchial balloon dilatation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noticed that the tip of the device peeled.The procedure was completed with another pulmonary jagwire guidewire.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Visual evaluation of the returned guidewire revealed that the device does not have any visible failure, the distal tip is in good condition and all the outer diameter measurements are within the specifications.The complaint is not consistent with the returned guidewire that the tip of the device peeled.The guidewire did not present any visual issue and it worked as intended.Returned device review includes visual and dimensional evaluations, which showed no evidence of either the alleged issue or any defect that could have contributed to the event reported.Therefore the most probable cause for the complaint is not confirmed-returned.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 lot.

• Brand Name: PULMONARY JAGWIRE¿
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7274516
• Report Number: 3005099803-2018-00504
• Device Sequence Number: 11056896
• Product Code: MDM
• UDI-Device Identifier: 08714729455813
• UDI-Public: 08714729455813
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K022059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2019
• Device Model Number: M00515171
• Device Catalogue Number: 1517
• Device Lot Number: 19835680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 60