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

Model Number A-EP-086

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 07/30/2018

Event Type  malfunction  

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 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
• Type of Device: CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL INC; 141 sal landrio drive; johnstown NY 12095
• Manufacturer (Section G): EPIMED INTERNATIONAL INC; 141 sal landrio drive; johnstown NY 12095
• Manufacturer Contact: kris knapp ; 141 sal landrio drive; johnstown, NY 12095
• MDR Report Key: 7838570
• MDR Text Key: 119652282
• Report Number: 1316297-2018-00009
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 00818788021069
• UDI-Public: 00818788021069
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K954584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other