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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL MAXI LD PTA F7 110 20X40; DILATOR, ESOPHAGEAL
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CORDIS CASHEL MAXI LD PTA F7 110 20X40; DILATOR, ESOPHAGEAL Back to Search Results
Model Number 4162040L
Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2018
Event Type  malfunction  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, after opening the package for three maxi ld balloon catheters (pta f7 110 20x40), it was found that the inner sterile packaging was leaked.There was no patient injury reported.The devices will not be returned for analysis.The devices were stored in the lab sealed and dry, with a special storage cabinet.There was no damage noted to the outer packaging.The integrity of the sterile pouch was not compromised.It is not possible that the product had been purposely opened in anticipation of use, and when not used was reshelved.The actual product was not damaged.The product was not used.
 
Manufacturer Narrative
As reported, after opening the package for three maxi ld balloon catheters (pta f7 110 20x40), it was found that the inner sterile packaging was leaked.There was no patient injury reported.The devices will not be returned for analysis.The devices were stored in the lab sealed and dry, with a special storage cabinet.There was no damage noted to the outer packaging.The integrity of the sterile pouch was not compromised.It is not possible that the product had been purposely opened in anticipation of use, and when not used was reshelved.The actual product was not damaged.The product was not used.Case-2018-00035215-1: three non-sterile units of maxi ld pta f7 110 20x40 were received coiled inside a plastic bag, the units were identified as unit 1 to 3.The analysis of unit 1 was documented on case-2018-00035215-1.Per analysis of the unit 1; neither the inner pouch nor the outer package was received for analysis.Per visual analysis, the balloon was received already inflated/deflated.Additionally, the body of the device received was found kinked at 24.2cm, at 44.4cm, at 46.0cm, at 67.0cm and at 80.2cm from the distal end.No other issues were observed.The dimensional analysis to measure the seal width was not performed since the product¿s inner pouch was not received for analysis.A device history record (dhr) review of lot 17654397 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Case-2018-00035215-2: three non-sterile units of maxi ld pta f7 110 20x40 were received coiled inside a plastic bag, the units were identified as unit 1 to 3.The analysis of unit 2 was documented on case-2018-00035215-2.Per analysis of the unit 2; neither the inner pouch nor the outer package was received for analysis.Per visual analysis, the balloon received was not inflated and the protective tube was in its manufacturing position.Additionally, the body of the device received was found kinked at 11.9cm, at 37.6cm, at 58.5cm, at 60.7cm, at 81.0cm and at 108.4cm from the distal end.No other issues were observed.The dimensional analysis to measure seal width was not performed since the product¿s inner pouch was not received for analysis.A device history record (dhr) review of lot 17650850 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Case-2018-00035215-3: three non-sterile units of maxi ld pta f7 110 20x40 were received coiled inside a plastic bag, the units were identified as unit 1 to 3.The analysis of unit 3 was documented case-2018-00035215-3.Per analysis of the unit 3; neither the inner pouch nor the outer package was received for analysis.Per visual analysis, the balloon received was not inflated and the protective tube was in its manufacturing position.Additionally, the body of the device received was found kinked at 20.6cm, at 35.5cm, at 49.3cm, at 67.2cm, at 79.6cm, at 91.2cm and at 103.2cm from the distal end.No other issues were observed.The dimensional analysis to measure seal width was not performed since the product¿s inner pouch was not received for analysis.A device history record (dhr) review of lot 17650850 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported ¿packaging/pouch/box compromised sterility sterile barrier breached¿ could not be confirmed through analysis of the returned devices since the products¿ inner pouches were not received.The exact cause of the issue experienced by the customer could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the issue experienced by the customer.However, the kinked conditions found may be due to handling during shipping for analysis since none of the packaging was received.As warned in the instructions for use, which is not intended as a mitigation, ¿do not use open or damaged packages.¿ neither the product analyses nor the dhr reviews suggests that the event reported could be related to the manufacturing process.Therefore, no corrective/preventive actions will be taken at this time.
 
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Brand Name
MAXI LD PTA F7 110 20X40
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
MDR Report Key7798684
MDR Text Key117706960
Report Number9616099-2018-02325
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
PMA/PMN Number
K023907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2018
Device Model Number4162040L
Device Catalogue Number4162040L
Device Lot Number17650850
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2018
Date Manufacturer Received07/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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