MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number	D128207
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.We are working on the manufacture record evaluation (mre), once we get more information it will be submitted in the supplemental.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a pentaray nav high-density mapping eco catheter, and a possible clot issue occurred.During the ablation procedure, the pentaray nav eco catheter was not irrigating.The doctor noticed there was blood backing up in the port.At the end of the case, when he pulled the pentaray out, he could not flush it.No clot was observed in or near the splines.Due to not being able to flush the catheter, the doctor concluded there must be clot in the inner lumen.No error messages were observed on any biosense webster inc.(bwi) equipment.The patient was administered an unknown anticoagulant during the case.The activated clotting time (act) was maintained throughout the case and checked every 15 minutes.No patient consequences were reported.The patent did not exhibit any neurological symptoms, since the procedure was completed.The observed irrigation issue has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9674229
• Report Number: 2029046-2020-00189
• Device Sequence Number: 379613
• Product Code: MTD
• UDI-Device Identifier: 10846835012217
• UDI-Public: 10846835012217
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

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: 06/09/2022
• Device Model Number: D128207
• Device Catalogue Number: D128207
• Device Lot Number: 30241798L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1