MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC 20G SPIROL; CATHETER

Model Number	A-EP-029
Medical Device Problem Codes	Device Issue (2379); Device Handling Problem (3265)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon arrival, the catheter was decontaminated per sop-021 (handling biologically contaminated product).After decontamination, the returned devices were examined.The 20g spirol catheter in question was returned fully intact.The catheter was fully inserted into the returned stingray connector to where the catheter's proximal depth mark properly aligned within the connector's shovel portion.A broken tongue depressor was attached with medical tape to the spirol catheter approximately 6" from the catheters proximal end.An orange piece of tape was observed wrapped around the returned stingray connector.Also, a kink was observed in the catheter approximately 16" from the catheters proximal end.After examination, a flow test was conducted using the returned devices and a syringe filled with water.During flow testing, water could be seen expelling from the catheter wall at the location where the abovementioned kink was observed.Next, the kink in the catheter was examined using the ce-180 (ram optical measurement system).During this examination, it was evident that the catheter's internal spring was severely twisted at the location of the kink.What appeared to be a tear in the catheter wall was also observed during this examination.Epimed suspects that the tongue depressor that the account had attached to the catheter using medical tape could have contributed to the reported complaint.Epimed was unable to gather information related to why the tongue depressor was attached to the catheter.Epimed suspects it is possible that the catheter may have become caught on the tongue depressor and subsequently became tangled and/or damaged.However, it is also possible that the catheter became tangled while the patient was moving and/or rolling over the catheter while it was still in situ.Epimed does not recommend any modification of the device(s) by the end-user.Epimed only recommends the use of the device(s) in accordance to the instructions listed in the ifu.Next, the batch history records were reviewed for the lot in question.No abnormalities related to the reported complaint were discovered during review of this lot.The lot passed all applicable inspections and testing.Next, the previous 5 years of complaint history was electronically reviewed for similar complaints; however, no similar complaints were found.Because of this, epimed has deemed this complaint to be isolated.However, epimed will continue to monitor all future similar complaints for tracking and trending purposes.
Event or Problem Description
Removed as per protocol, however had been kinked and leaking.

• Brand Name: 20G SPIROL
• Common Device Name: CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL INC; 141 sal landrio drive; johnstown NY 12095
• MDR Report Key: 7639362
• Report Number: 1316297-2018-00007
• Device Sequence Number: 1529677
• Product Code: BSO
• UDI-Device Identifier: 00818788021649
• UDI-Public: 00818788021649
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K981329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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: Physician
• Device Expiration Date: 01/30/2023
• Device Model Number: A-EP-029
• Device Catalogue Number: 195-1936
• Device Lot Number: 1638558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR