MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPO GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	8080
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that an extra hole in the device was noted.A 5f expo guide catheter was selected for use.It was observed that there was an extra hole in the device at the yellow tip of the catheter.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Date of event was approximated.Mfr site address 2: no.20905 int.A.Col.,cd.Industrial, 22444.Device evaluated by mfr.: returned product consisted of an expo diagnostic catheter.The curve and the catheter shaft were checked for damage.The catheter shaft showed no damage; however, the tip showed damage in the form of protruding material.The devices are 100% tactile tested during the inspection process.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that an extra hole in the device was noted.A 5f expo guide catheter was selected for use.It was observed that there was an extra hole in the device at the yellow tip of the catheter.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: EXPO GUIDE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8615966
• Report Number: 2134265-2019-05361
• Device Sequence Number: 16734072
• Product Code: DQO
• UDI-Device Identifier: 08714729192985
• UDI-Public: 08714729192985
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 02/11/2021
• Device Model Number: 8080
• Device Catalogue Number: 8080
• Device Lot Number: 0060171511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1