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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 5F X 5CM -JAPAN INTRODUCER, CATHETER

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BARD ACCESS SYSTEMS UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 5F X 5CM -JAPAN INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/12/2018
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that the sheath had split finely even though the operator had incised the dermis and undermined sufficiently. The operator completed the operation using a preliminary microintroducer without any problem. No patient harm has been reported.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the complaint of a damaged introducer was confirmed, and the damage appeared to be related to use of the device. One 5fr x 5cm ptfe microintroducer was returned for investigation. The sheath had not been split. The distal tip of the vessel dilator exhibited plastic deformation instead of the standard circular orifice with rounded tip. This type of deformation to the vessel dilator material is consistent with damage caused from abrasion as the introducer is advanced over a guidewire. A portion of the edge along the distal tip of the sheath also exhibited compression damage, which can happen if the edge of the sheath inadvertently catches on the surrounding tissue or vessel during insertion. The increased angle between the introducer and the guidewire can be a factor in the damage. The undamaged section along the distal sheath edge revealed what appeared to be a smooth and proper transition. One of the precautions in the ifu states, ¿simultaneously advance the sheath and dilator with rotational motion to help prevent sheath damage. ¿ a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that the sheath had split finely even though the operator had incised the dermis and undermined sufficiently. The operator completed the operation using a preliminary microintroducer without any problem. No patient harm has been reported.
 
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Brand NameUNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 5F X 5CM -JAPAN
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key7253299
MDR Text Key100003731
Report Number3006260740-2018-00165
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K915167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0668950J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received03/06/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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