MAUDE Adverse Event Report: STERILMED, INC. IMAGING CATHETER; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	BIO10439072
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The photograph investigation was completed on june 12, 2020.According to the picture provided by the customer, it shows what appears to be a fully opened & exposed tyvek package and the handle of an imaging catheter.There also appears to be a filament up against the device¿s handle.No additional image of the remainder of the package or the device was provided.They reported a lot number 2120282 which is for model bio10439072, which matches the reported model.It cannot be confirmed from the photo that it is a reprocessed device, sterilmed packaging or that the device is related to lot 2120282.It can be observed that the packaging is open in an unknown environment; it cannot be assessed from the photo if the environment is a clean or controlled environment, or if the individual handling the product and taking the photo is wearing ppe or any head coverings.As the filament can be observed on the handle of the device (which is outside any usable length of the catheter), there can be no conclusion as to the origins of this debris on the exposed, unsterile package and product.The device history record (dhr) for the reported lot 2120282 was reviewed and all approved devices passed all visual and functional criteria prior to being distributed to the customer.The dhr shows the sealed, packaged devices passed the final visual inspection prior to being shipped to the customer.An mre was conducted and there are no identified internal actions.Per the instructions for use for reprocessed imaging catheter smi-420-300 rev.H, the user of the device is to ¿inspect the packaging, and the imaging catheter prior to use.If sterility appears compromised or the package/product appears damaged, do not use.¿ it is unclear whether the packaging and device were thoroughly evaluated prior to the package seal being opened.The size and placement of the filament, shown in the photograph, would appear to have been visible through the clear side of the packaging, if present.There is no verification or confirmation that any debris was in the package prior to its opening.The reported issue is not confirmed.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with an imaging catheter, and foreign material was identified inside the device packaging.It was reported that during the procedure, while opening the sterile reprocessed imaging catheter, a hair-like substance was found inside of it.The surgeon finished the procedure with another instrument.No patient consequence was reported.Additional clarification was received on the event.The hair was found on the usable portion of the catheter.The procedure was completed with another cartosound catheter.The intent of the procedure was not altered as a result of the event.The foreign material on the catheter that was identified while opening the sterile packaging was assessed as a mdr reportable event.
Additional Manufacturer Narrative
During an internal review on june 18, 2020, identified a correction to 3500a initial labeled for single use? as it should have reflected as "no"; however was omitted.Method codes field should have included "device not returned" code.Therefore, both of these fields have been processed accordingly.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
The sterilmed product analysis lab received the device for evaluation.The device was returned in a sealed biohazard bag, but not with any of the original packaging.It could not be determined if the device had been wiped down prior to being placed inside this bag, but an extensive search was conducted and there was no hair filament found on any part of the device.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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with an imaging catheter.It was reported that during the procedure, while opening the sterile reprocessed imaging catheter, a hair-like substance was found inside of it.The surgeon finished the procedure with another instrument.No patient consequence was reported.Additional clarification was received on the event.The hair was found on the usable portion of the catheter.The procedure was completed with another cartosound catheter.The intent of the procedure was not altered as a result of the event.According to the picture provided by the customer, it shows what appears to be a fully opened and exposed tyvek package and the handle of an imaging catheter.The product analysis was performed as appropriate in order to find a root cause of the complaint.Device evaluation summary was completed on july 16, 2020: a device was received from biosense webster, inc.And this investigation was created to capture the evaluation of the returned product.The device was returned in a sealed biohazard bag, but not with any of the original packaging.It could not be determined if the device had been wiped down prior to being placed inside this bag, but an extensive search was conducted and there was no hair filament found on any part of the device.The original provided photo shows the device with what appears to be a strand of hair.No additional image of the original packaging or the product still sealed inside the original packaging was ever provided.Lot number 2120282 was originally reported, which is for model bio10439072, which matches the reported model.The device was returned with a flag label with id number 605583, which is verified to be reprocessed under lot 2120282.As the filament is only observed in the photo on the handle of the device (which is outside any usable length of the catheter), there can be no conclusion as to the origins of this debris on the exposed, unsterile package and product.The device history record (dhr) for the reported lot 2120282 was reviewed and all approved devices passed all visual and functional criteria prior to being distributed to the customer.The dhr shows the sealed, packaged devices passed the final visual inspection prior to being shipped to the customer.A manufacturing record evaluation (mre) was conducted and there are no identified internal actions.Per the instructions for use for reprocessed imaging catheter smi-420-300 rev.H, the user of the device is to ¿inspect the packaging, and the imaging catheter prior to use.If sterility appears compromised or the package/product appears damaged, do not use.¿ it is unclear whether the packaging and device were thoroughly evaluated prior to the package seal being opened.The size and placement of the filament, shown in the photograph, would appear to have been visible through the clear side of the packaging, if present.There is no verification or confirmation that any debris was in the package prior to its opening.The reported issue is not confirmed.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: IMAGING CATHETER
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 10171783
• Report Number: 2134070-2020-00004
• Device Sequence Number: 17053181
• Product Code: OWQ
• UDI-Device Identifier: 10888551014458
• UDI-Public: 10888551014458
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K110076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/22/2020

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: 12/30/2020
• Device Model Number: BIO10439072
• Device Catalogue Number: R10439072
• Device Lot Number: 2120282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 06/18/2020; 06/18/2020; 07/16/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 06/18/2020; 07/16/2020; 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BRAND CARTOSOUND CATHETER