MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	M00556531
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was retained and will not be returned for evaluation; 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 or Problem Description
It was reported to boston scientific corporation that a jagwire guidewire was inspected on an unknown event date.According to the complainant, upon inspection of the product at the distribution site, it was found that the seal part was peeled off.Reportedly, there was no patient involvement and this device was not used in a procedure.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire guidewire was inspected on an unknown event date.According to the complainant, upon inspection of the product at the distribution site, it was found that the seal part was peeled off.Reportedly, there was no patient involvement and this device was not used in a procedure.
Additional Manufacturer Narrative
Block h6 (device codes): the problem code 1444 captured the reportable event of seal compromised.Block h10: visual analysis of the jagwire revealed that the device returned in its sealed pouch shows that the heat seal runs throughout the entire length of the pouch without any breakage.The device was visually inspected through the pouch and no visual issues/defects were identified.Therefore, complaint was not confirmed.Based on the information available and the analysis performed, the investigation conclusion code for the reported event will be documented as no problem detected since the complaint included a returned device review (visual testing) which showed no evidence of either the alleged issue or any defect which could have contributed to the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: JAGWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10905263
• Report Number: 3005099803-2020-05758
• Device Sequence Number: 545587
• Product Code: OCY
• UDI-Device Identifier: 08714729874515
• UDI-Public: 08714729874515
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: Other
• Device Expiration Date: 06/18/2023
• Device Model Number: M00556531
• Device Catalogue Number: 5653
• Device Lot Number: 0025615587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1