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U.S. Department of Health and Human Services

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

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EPIMED INTERNATIONAL INC. EPIMED BREVI-XL RADIO-OPAQUE EPIDURAL CATHETER Back to Search Results
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catheter was reviewed.The catheter coating was not sheared, but skived, and as a result, the distal tip of the catheter was retracted within the fep outer coating.Although the fep portion of the catheter had become skived, all of the catheter coating was intact and accounted for.During review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.".
 
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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 Key6024254
MDR Text Key57291576
Report Number1316297-2016-00019
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Reporter Country CodeHR
PMA/PMN Number
K954584
Number of Events Reported1
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 Date05/31/2021
Device Model NumberA-EP-084
Device Catalogue Number155-2340
Device Lot Number11407512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/13/2016
Initial Date FDA Received10/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age67 YR
Patient Weight90
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