MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC BREVI-XL/2; CATHETER

Model Number	A-EP-086
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On august 8, 2018, epimed received notification of an incident involving a sheared 18g brevi-xl/2 catheter from (b)(6).The account stated that the physician used a 16 ga epimed introducing needle via the s1 foramen to target scarring near l5/s1.When the physician entered the s1 foramen, the tip of the catheter got stuck in the dorsal aspect of the s1 foramen.Despite tugging on the catheter, the physician was unable to dislodge it.Because of this, the decision was made to attempt to retrieve the catheter tip by dissecting down the length of the catheter.Subsequently, the tip of the catheter broke off and was irretrievable.The decision was made to terminate the procedure and the catheter tip remains in situ.The account has reported that the patient has been examined further and has had no new radicular symptoms as a result of this reported incident and is reported to be doing well.Although the device was not available for return to epimed, a batch history record review was conducted for the lot in question; revealing no abnormalities within the reported lot related to the reported event.
Event or Problem Description
On august 8, 2018, epimed received notification of an incident involving a sheared 18g brevi-xl/2 catheter from (b)(6).The account stated that the physician used a 16 ga epimed introducing needle via the s1 foramen to target scarring near l5/s1.When the physician entered the s1 foramen, the tip of the catheter got stuck in the dorsal aspect of the s1 foramen.Despite tugging on the catheter, the physician was unable to dislodge it.Because of this, the decision was made to attempt to retrieve the catheter tip by dissecting down the length of the catheter.Subsequently, the tip of the catheter broke off and was irretrievable.The decision was made to terminate the procedure and the catheter tip remains in situ.

• Brand Name: BREVI-XL/2
• Common Device Name: CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL INC; 141 sal landrio drive; johnstown NY 12095
• MDR Report Key: 7838570
• Report Number: 1316297-2018-00009
• Device Sequence Number: 2447315
• Product Code: BSO
• UDI-Device Identifier: 00818788021069
• UDI-Public: 00818788021069
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K954584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2018

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: 07/31/2022
• Device Model Number: A-EP-086
• Device Catalogue Number: 155-2342
• Device Lot Number: 11428257
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/31/2018
• 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