MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) CARTO 3 EXTERNAL REFERENCE PATCH; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number D-1283-02

Device Problem Sticking (1597)

Patient Problem Skin Tears (2516)

Event Date 07/29/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for atrioventricular nodal reentrant tachycardia (avnrt)/wolff-parkinson-white (wpw) with a carto 3 external reference patch and suffered a skin tear requiring a dressing.Post-ablation, after removing the carto 3 disposable back patch, a significant blister/skin tear was noted on the upper back/neck area.A piece of skin was adhered to the patch.It is unknown if a blister was present pre-procedure.The patient did not require extended hospitalization as a result of this adverse event.The patient has improved.Patient was scheduled to be discharged as scheduled.Injury will be evaluated on a follow-up appointment.The physician's opinion regarding the cause of the adverse event is that it was related to a bwi product, specifically, that the patch adhesive was too sticky.It was noted that the adhesive should not have pulled the skin off of a young athletic male patient.

• Brand Name: CARTO 3 EXTERNAL REFERENCE PATCH
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5887401
• MDR Text Key: 52493178
• Report Number: 2029046-2016-00103
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: D-1283-02
• Device Catalogue Number: CREFP6
• Device Lot Number: OEM_D-1283-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 79