MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 014; WIRE, GUIDE, CATHETER

Catalog Number	M001468050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record could not be performed because the lot number was not reported.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Based on the currently available information, the cause of the reported event could not be determined.
Event or Problem Description
A medwatch form (mw5088033) was received which reported that a foreign body was noted on chest x-ray and retrospectively identified on abdominal x-ray after the procedure for picc line exchange along with replacement of peritoneal dialysis catheter.Therefore, the patient under went cardiac catherization under anesthesia for removal of the foreign body from her left pulmonary artery.Assessment of the foreign body by pathology using light microscopy suggests that the foreign body is consistent in size and color with the guidewire (subject device) used for picc line exchange.

• Brand Name: TRANSEND EX 014
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101
• MDR Report Key: 8923560
• Report Number: 3008853977-2019-00061
• Device Sequence Number: 1904223
• Product Code: DQX
• UDI-Device Identifier: 08714729187332
• UDI-Public: 08714729187332
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M001468050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention