MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	10438577
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biosense webster inc.Product analysis lab received the device for evaluation on 1/20/2021.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure for atrial fibrillation (afib) with a soundstar catheter where a foreign material issue occurred.It was reported when the catheter was opened out of the box there was foreign material described as ¿an amber clear tape¿ and the biosense webster, inc.Representative was concerned of any adhesive residue on the soundstar catheter.The catheter cable was replaced and the issue remained.The catheter was replaced and the issue resolved.There was no report of patient consequence.The origin of the foreign material was unknown.The original packaging was discarded by the account.The foreign material was assessed as a mdr reportable issue.
Additional Manufacturer Narrative
The product investigation was completed on (b)(6) 2021.It was reported that a patient underwent a cardiac ablation procedure for atrial fibrillation (afib) with a soundstar catheter where a foreign material issue occurred.It was reported when the catheter was opened out of the box there was foreign material described as ¿an amber clear tape¿ and the biosense webster, inc.Representative was concerned of any adhesive residue on the soundstar catheter.The catheter cable was replaced and the issue remained.The catheter was replaced and the issue resolved.There was no report of patient consequence.The origin of the foreign material was unknown.An analysis was performed on the picture that was provided by the customer.According to the picture, amber clear tape was observed on the tip.A device history record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was visually inspected and appeared in normal condition.The reported foreign material was not returned with the device, it could be lost during the decontamination process and it could not be physically analyzed.Supplier quality was notified about this issue and manufacturer performed an investigation.Root cause was determined to be a human error during the packaging process since it was missed to remove the tape of the identification tag.Corrective action was a procedure enhancement revision for visual inspection of label identification.A manufacturing record evaluation was performed and no internal action related to the complaint was found during the review.Explanation of codes: related to device analysis ¿ type of investigation: analysis of production records (b14); testing of actual/suspected device (b01) investigation findings: no findings available (c20) investigation conclusions: cause not established (d15) related to picture analysis ¿ type of investigation: analysis of data provided by user/third party (b15); analysis of production records (b14) investigation findings: inappropriate material (c0602); appropriate term/code not available (c22) investigation conclusions: cause not established (d15) h6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: SOUNDSTAR
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11206394
• Report Number: 2029046-2021-00093
• Device Sequence Number: 3381952
• Product Code: OBJ
• UDI-Device Identifier: 10846835008838
• UDI-Public: 10846835008838
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K112050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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: 09/23/2021
• Device Model Number: 10438577
• Device Catalogue Number: 10438577
• Device Lot Number: E5094125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; UNKNOWN BRAND CATHETER; UNKNOWN BRAND CATHETER CABLE