MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC. EPIMED BREVI-XL RADIO-OPAQUE EPIDURAL CATHETER

Model Number A-EP-084

Device Problems Entrapment of Device (1212); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 09/10/2016

Event Type  malfunction  

Manufacturer Narrative

Upon return, the 19g brevi-xl catheter was reviewed.The catheter coating was not sheared, but skived, and as a result, the distal tip of the catheter was retracted within the fep outer coating.Although the fep portion of the catheter had become skived, all of the catheter coating was intact and accounted for.During review of the ihr-022s (epimed initial complaint form - supplemental), the physician stated that she had drawn back on the catheter while the needle was in place.Epimed's ifu pi-004 rev.3 warns against this.It was observed that the direction of the skive was tracking from the proximal end toward the distal end of the catheter.This finding is indicative of an attempt to remove the catheter while the catheter was either still "lodged" within the patient and/or while the needle was still positioned within the patient (i.E.The catheter may have become caught on the needle's heel of the bevel/tip).The corresponding 16g rx-2 coude needle was unavailable for review and had been discarded by the account.The lot number of the needle was not made available to epimed.However, the batch history records for the catheter and the potential bhr's for the needle (based on the account's sales history) were reviewed, finding no abnormalities within the manufacturing lots.Epimed has reminded the account to properly review the ifu for spring guide epidural catheter products prior to future procedures.Epimed believes if the ifu was followed, it may have prevented damage to the catheter in question.There was no patient injury or adverse events reported as a result of this complaint.

Event Description

On september 14, 2016, epimed received an email from clinical sales consultant, (b)(6), with an attached complaint from (b)(6).The complaint stated, "at the start of procedure, after introducing the catheter through the rx-2 needle, i noticed that i couldn't advance the catheter above l4/l5.I decided to remove the catheter out.Then, i noticed a sheared catheter.".

• Brand Name: EPIMED BREVI-XL RADIO-OPAQUE EPIDURAL CATHETER
• Type of Device: EPIDURAL 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: nathanael wrabel ; 141 sal landrio drive; johnstown, NY 12095 ; 5187250209
• MDR Report Key: 6024254
• MDR Text Key: 57291576
• Report Number: 1316297-2016-00019
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K954584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2016

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
• Device Operator: Physician
• Device Expiration Date: 05/31/2021
• Device Model Number: A-EP-084
• Device Catalogue Number: 155-2340
• Device Lot Number: 11407512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 90