MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) CABLE, SURELINK¿ CABLE FOR DIAGNOSTIC CATHETER; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number	M004560001P0
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mewatch wil be filed.(b)(4).
Event or Problem Description
It was reported that the blue seal on the package was open (peeled off).The device was not used in a procedure and there was no patient involvement.
Event or Problem Description
It was reported that the blue seal on the package was open (peeled off).The device was not used in a procedure and there was no patient involvement.
Additional Manufacturer Narrative
Device evaluated by mfr: the cable was received in a sealed shipping pouch; the seal of the pouch was intact as well as the paper back and clear plastic front.No blue seal was present.It is suspected that the opened blue seal the customer reported was on the shipping box which was not returned.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).

• Brand Name: CABLE, SURELINK¿ CABLE FOR DIAGNOSTIC CATHETER
• Common Device Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7521858
• Report Number: 2134265-2018-04378
• Device Sequence Number: 11160432
• Product Code: DSA
• UDI-Device Identifier: 08714729879664
• UDI-Public: 08714729879664
• Combination Product (Y/N): N
• PMA/510(K) Number: K013598
• 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): 04/26/2018

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: 01/23/2020
• Device Model Number: M004560001P0
• Device Catalogue Number: 560001P
• Device Lot Number: 21647433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1