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

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 04/26/2018

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 108764522
• Report Number: 2134265-2018-04378
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 08714729879664
• UDI-Public: 08714729879664
• Combination Product (y/n): N
• PMA/PMN Number: K013598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1