MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC SPIROL; CATHETER

Model Number	A-EP-407
Medical Device Problem Codes	Mechanical Problem (1384); Device Handling Problem (3265); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On july 24, 2018, the account reported to epimed that the tip of the catheter was retained within the patient upon catheter removal.The account reported that approximately 1.5 cm of the catheter remained in the caudal space.Upon return to epimed, the catheter was examined.The tip of the catheter appeared to be missing from the device.Measurement testing was conducted, and it was determined that approximately 2 cm of the catheter's distal tip was sheared.The catheter was examined using the ce-180 (ram optical measurement system).During this examination, it was noticed that the sheared portion of the catheter appeared rough in texture.The catheter did not appear to be cut as would be expected if the catheter were withdrawn against a needle tip.The reporting account stated that they were using a becton dickinson angiocath device in conjunction with the epimed catheter during the reported procedure.The angiocath is designed for the end-user to first remove an introducer needle from a plastic cannula before inserting the catheter through the plastic cannula and into the patient.It is highly unlikely that the catheter became sheared through an interaction with the cannula of an angiocath.The reporting account did not return the reported angiocath to epimed for examination and epimed did not conduct testing on an angiocath device.However, epimed does manufacture a blunt access cannula (bac), which is similar in design to becton dickinson's angiocath.Because of this, skive testing was conducted on the returned catheter using an epimed bac.The catheter did not skive during this testing.Based on all available evidence, epimed could not definitively determine the root cause of the reported complaint.However, epimed suspects that the catheter in question may have become caught on scar tissue or an internal structure during the procedure and subsequently became damaged.As of (b)(6) 2018, the reporting account stated that the patient is doing well.
Event or Problem Description
The tip of the caudal catheter was retained in the patient upon catheter removal.About 1.5 cm of the catheter tip remains in the caudal space.

• Brand Name: SPIROL
• Common Device Name: CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL INC; 141 sal landrio drive; johnstown NY 12095
• MDR Report Key: 7814105
• Report Number: 1316297-2018-00008
• Device Sequence Number: 1437810
• Product Code: BSO
• UDI-Device Identifier: 00818788022264
• UDI-Public: 00818788022264
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K981329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 08/24/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: A-EP-407
• Device Catalogue Number: 193-2036
• Device Lot Number: 16368577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other